| 商品名称 | Vectibix |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Colorectal Neoplasms |
| 通用名/非专利名称 | panitumumab |
| 活性成分 | panitumumab |
| 产品号 | EMEA/H/C/000741 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XC08 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2007/12/03 |
| 上市许可开发者/申请人/持有人 | Amgen Europe B.V. |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/03/13 |
| 修订号 | 35 |
| 治疗适应症 | Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with Folfox or Folfiri. in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/04 |
| 最后更新日期 | 2025/05/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vectibix |